Study of subcutaneous (SC) belimumab in pediatric participants with systemic lupus erythematosus (SLE)

Participants who meet the 1997 American College of Rheumatology (ACR) criteria for the classification of SLE;

• Have or have had in series 4 or more of the 11 ACR criteria for the classification of SLE.

Are on a stable SLE treatment regimen, “Stable treatment at Baseline” consists of any of the following medications (alone or in combination) administered for a period of at least 30 days prior to Day 1;

• Corticosteroids [prednisone or prednisone equivalent up to 0.5 milligram per kilogram per day (mg/kg/day)], for those participants on alternating day doses of steroids, use the average of 2 daily doses to calculate the average daily steroid dose.
• Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (e.g. tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine or thalidomide.
• Anti-malarials (e.g. hydroxychloroquine, chloroquine, quinacrine).
• Non-steroidal anti-inflammatory drugs (NSAIDs)
• New SLE therapy must not be added within 30 days of Day 1.

Male and/or female;

• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• No contraceptive measures are required for male participants.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies, Is not a woman of childbearing potential (WOCBP) or Is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the belimumab treatment period and for at least 16 weeks, corresponding to the time needed to eliminate any study intervention(s) (e.g., 5 terminal half-lives), after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test (serum or as required by local regulations) within 35 days before the first dose of belimumab.
• The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

Have acute or chronic infections requiring management, as follows;

• Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria).
• Use of parenteral [IV or Intramuscular (IM)] antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) for infection within 60 days of Day 1.

Have a Grade 3 or greater laboratory abnormality based on the protocol defined adverse event and laboratory value severity grade scale except for the following that are allowed;

• Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment.
• Stable Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy.
• Stable Grade 3 hypoalbuminemia due to lupus nephritis, and not related to liver disease or malnutrition.
• Any grade proteinuria.
• Stable Grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis, and not related to alcoholic liver disease, uncontrolled diabetes or viral hepatitis. If present, any abnormalities in the alanine amininotransferase (ALT) and or aspartate aminotransferase (AST) must be <= Grade 2.
• Stable Grade 3 neutropenia; or stable Grade 3 lymphopenia; or stable Grade 3 leukopenia, due to SLE.

Have received any of the following within 364 days of Day 1;

• Treatment with any B-cell targeted therapy [e.g., rituximab, other anti-CD20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], B lymphocyte stimulator (BLyS)-receptor fusion protein [BR3], transmembrane activator attached to the Fc portion of an immunoglobulin [TACI Fc]).
• Abatacept.
• Any biologic investigational agent.

Have received any of the following within 90 days of Day 1;

• Anti-tumor necrosis factor (TNF) therapy (e.g., adalimumab, etanercept, infliximab).
• Interleukin-1 receptor antagonist (anakinra).
• Intravenous immunoglobulin (IVIG).
• Plasmapheresis.

Have received any of the following within 30 days of Day 1;

• IV cyclophosphamide.
• A non-biologic investigational agent (30 day window or 5 half-lives, whichever is greater).
• Any new immunosuppressive/immunomodulatory agent.
• High dose prednisone or equivalent (>1.5 mg/kg/day) or any intramuscular or intravenous steroid injection.